Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

The Global Regulatory Lead is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others.

Your primary areas of focus are:

• Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally
• Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings
• Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators
• Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requested
• Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user fees
• Monitor, interpret, and communicate changes to the global regulatory landscape as required
• Serve as the regulatory affairs business partner to local commercialization teams
• Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
• Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams

Desired Skills and Experience:

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA
• PhD or PharmD preferred
• Prior experience working in rapidly growing pharmaceutical organizations is desirable
• A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in United States
• Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
• Affinity with science and ability to interact with scientists and clinicians
• Experience interacting with regulatory authorities, especially the FDA and EMA
• Ability to speak and interact with a diverse group of individuals on technical and business topics
• Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
• Track record of successful interactions with regulatory and health authorities
• You are a connector, building relationships and partnering across the organization to achieve the company goals
• You excel in a fast-paced, results-driven, highly accountable environment
• You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done
• You show strong leadership with proven ability to build, motivate and develop a team
• You resonate with the values of argenx and you are ready to drive the Company Culture
• You combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goal